Consultation on Penflufen, Proposed Maximum Residue Limit PMRL2019-01

Notice to the reader:

This consultation is now closed.

Pest Management Regulatory Agency
6 February 2019
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2019-1E-PDF (PDF version)

Under the authority of the Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) has concluded that the addition of new uses on bulb vegetables to the product label of PEN 240FS Flowable Fungicide, containing technical grade penflufen, is acceptable. The specific uses approved in Canada are detailed on the label of PEN 240FS Flowable Fungicide, Pest Control Products Act Registration Number 30359.

The evaluation of this penflufen application indicated that the end-use product has value and, the human health and environmental risks associated with the new uses are acceptable.

Before registering a pesticide for food use in Canada, the PMRA must determine the quantity of residues that are likely to remain in or on the food when the pesticide is used according to label directions and that such residues will not be a concern to human health. This quantity is then legally established as a maximum residue limit (MRL). An MRL applies to the identified raw agricultural food commodity as well as to any processed food product that contains it, except where separate MRLs are specified for the raw agricultural commodity and a processed product made from it.

Consultation on the proposed MRL for penflufen is being conducted via this document (see Next Steps, the last section of this document). A summary of the field trial data used to support the proposed MRL can be found in Appendix I.

To comply with Canada's international trade obligations, consultation on the proposed MRL is also being conducted internationally by notifying the World Trade Organization, as coordinated by the Canada's Notification Authority and Enquiry Point.

The proposed MRL, to be added to the MRLs already established for penflufen, is as follows:

Table 1 Proposed Maximum Residue Limit for Penflufen
Common Name Residue Definition MRL (ppm)Footnote 1 Food Commodity
Penflufen N-[2-(1,3-dimethylbutyl)phenyl]-5-fluoro-1,3-dimethyl-1H-pyrazole-4-carboxamide 0.01 Bulb vegetables (crop subgroup 3-07A)


Footnote 1

1 ppm = parts per million

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MRLs are proposed for each commodity included in the listed crop groupings in accordance with the Residue Chemistry Crop Groups webpage in the Pesticides section of

MRLs established in Canada may be found using the Maximum Residue Limit Database on the Maximum Residue Limits for Pesticides webpage. The database allows users to search for established MRLs, regulated under the Pest Control Products Act, both for pesticides or for food commodities.

International Situation and Trade Implications

The MRL proposed for penflufen in Canada is the same as the corresponding American tolerance as listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide. Currently, there are no Codex MRLs Footnote 1 listed for penflufen in or on any commodity on the Codex Alimentarius Pesticide Index webpage.

Next Steps

The PMRA invites the public to submit written comments on the proposed MRL for penflufen up to 75 days from the date of publication of this document. Please forward your comments to Publications. The PMRA will consider all comments received before making a final decision on the proposed MRL. Comments received will be addressed in a separate document linked to this PMRL. The established MRL will be legally in effect as of the date that it is entered into the Maximum Residue Limit Database.

Appendix I

Summary of Field Trial Data Used to Support the Proposed Maximum Residue Limit

Residue data for penflufen in dry bulb onions and green onions were submitted to support the domestic use of PEN 240FS Flowable Fungicide on bulb vegetables.

Maximum Residue Limit

The recommendation for an MRL for penflufen was based upon the submitted field trial data, and the guidance provided in the OECD MRL Calculator. Table A1 summarizes the residue data used to calculate the proposed MRL for bulb vegetables.

Table A1 Summary of Field Trial Data Used to Support the MRL
Commodity Application Method/ Total Application Rate (g a.i./100 kg seed)Footnote 1 Preharvest Interval (days) Lowest Average Field Trial Residues (ppm) Highest Average Field Trial Residues (ppm)
Dry bulb onions Seed Treatment/ 221-243 105-245 < 0.01 < 0.01
Green onions Seed Treatment/ 226-241 55-83 < 0.01 < 0.01


Footnote 1

g a.i./100 kg seed = grams of active ingredient per 100 kilograms of seed

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Following the review of all available data, an MRL as proposed in Table 1 is recommended to cover residues of penflufen. Residues of penflufen in these crop commodities at the proposed MRL will not pose an unacceptable risk to any segment of the population, including infants, children, adults and seniors.


Footnote 1

The Codex Alimentarius Commission is an international organization under the auspices of the United Nations that develops international food standards, including MRLs.

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